| Device |
combined acoustic and electrical external stimulation device for the relief of tinnitus |
| Definition |
A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus. |
| Physical State |
The device may include a headphone for sound stimulation, a electrical stimulator for transmucosal/transcutaneous electrical stimulation, and a controller (hardware and software) to generate and control the sound and electrical stimulation. |
| Technical Method |
Uses a headphone to deliver sound stimulation and a transmucosal/transcutaneous electrical stimulator to deliver electrical stimulation. |
| Target Area |
Ear, tongue, skin etc. |
| Regulation Medical Specialty |
Ear Nose & Throat |
| Review Panel |
Ear Nose & Throat |
|---|
| Product Code | QVN |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
874.3410
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
